Mylan seeks approval for generic fibromyalgia drug

Drug maker hopes to become first to market generic version of Savella

PITTSBURGH — Mylan is challenging the patent protection on a drug used to treat fibromyalgia, prompting a lawsuit from the branded drug's manufacturers.

Mylan said Wednesday that Forest Labs and Royalty Pharma had sued it in the U.S. District Court for the District of Delaware in connection with its filing of a regulatory approval application with the Food and Drug Administration for milnacipran hydrochloride tablets in the 12.5-mg, 25-mg, 50-mg and 100-mg strengths. The drug is a generic version of Savella.

If Mylan is the first company to successfully file an approval application with the FDA for a generic version of Savella, it will receive 180 days of market exclusivity in which to compete directly with Forest following FDA approval.

Savella had sales of about $123 million during the 12-month period ended in June, according to IMS Health.


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